Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Differences in analyte values obtained from three different blood gas syringes for each analyzer tested
研究概览
简要总结
To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.
详细描述
This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Willing and able to independently sign an English Informed Consent
- •Have adequate veins for sampling blood from both right and left upper extremities
排除标准
- •Currently taking anti-coagulation medication
- •Have a known bloodborne disease or bleeding tendency
- •Have a known fear or adverse reaction to needles or blood
- •Women who are pregnant or nursing
结局指标
主要结局
Differences in analyte values obtained from three different blood gas syringes for each analyzer tested
时间窗: Blood analysis within 30 minutes of draw
For each of the analytes that are tested, the analyte values from each of the three (3) syringe types tested will be compared for each of the three (3) multi-parameter analyzers. Average values for each analyte per patient, syringe and analyzer will be used for the comparison of syringes for each analyzer.
次要结局
未报告次要终点